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NCT03345485 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
A Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Mundipharma Research Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 13
- Study locations
NCT03345485: Completed Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Mundipharma Research Limited.
NCT03345485 is a Phase 1 study of Ovarian Cancer and Endometrial Cancer that has completed, run by Mundipharma Research Limited. The registered enrollment target is 71 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (90% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345485, a Phase 1 study of Ovarian Cancer and Endometrial Cancer, has completed, sponsored by Mundipharma Research Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 13
- Study locations
Study Summary
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tinostamustine in subjects with advanced solid tumours. Subjects will be given Tinostamustine via intravenous infusion on Days 1 and 15 of a 4-week cycle, the dose and infusion time will vary depending on the phase of the study.
Primary Outcome
All TEAEs was reported from the first dose of study drug through the time of study drug discontinuation (at any time or Day 28 of the last treatment Cycle). All treatment-related TEAEs was followed until resolution or stabilization. For the purpose of regulatory reporting requirements, causal relationships of definite, probable, and possible was considered treatment-related. Number of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03. (June 2010).
Conditions Studied
Interventions
- DRUG Tinostamustine 60mg/m2 over 30min
- DRUG Tinostamustine 80mg/m2 over 30min
- DRUG Tinostamustine 100mg/m2 over 30min
- DRUG Tinostamustine 60mg/m2 over 60min
- DRUG Tinostamustine 80mg/m2 over 60min
Study Locations (13)
Other
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
- Istituto Europeo di Oncologia - Milan
- Erasmus MC Kanker Instituut - Rotterdam
California
- Cedars-Sinai Medical Center - Los Angeles
- Stanford University Medical Center - Palo Alto
Michigan
- University of Michigan - Ann Arbor
New York
- New York University - New York
Texas
- Mary Crowley Cancer Research - Dallas
Ontario, on
- Juravinski Cancer Centre - Hamilton
Quebec
- McGill University - Montreal
Vancouver, BC
- BC Cancer-Vancouver - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2023-03-29 |
| Phase | Phase 1 |
What the finished NCT03345485 record still lists
NCT03345485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (90% lower).
The record links to 5 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Tinostamustine 60mg/m2 over 30min is the first listed.
NCT03345485 lists 13 locations in 10 states (Other, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT03345485 about?
NCT03345485 is a clinical study titled "Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.". Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tin...
What is the current status of trial NCT03345485?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2017-11-08. Estimated completion is 2023-03-29.
What conditions does trial NCT03345485 study?
This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer, Small-cell Lung Cancer, Soft Tissue Sarcoma.
What interventions are being tested in trial NCT03345485?
The interventions under investigation include: Tinostamustine 60mg/m2 over 30min (DRUG), Tinostamustine 80mg/m2 over 30min (DRUG), Tinostamustine 100mg/m2 over 30min (DRUG), Tinostamustine 60mg/m2 over 60min (DRUG), Tinostamustine 80mg/m2 over 60min (DRUG).
Who is sponsoring clinical trial NCT03345485?
This trial is sponsored by Mundipharma Research Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345485 being conducted?
This trial has 13 study locations across California, Michigan, New York, Texas, Ontario, on. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03345485's enrollment target sits among peer trials
71 175th of 322 higher than 147 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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